MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-18 for TOLLOS CIRRUS 600LBS manufactured by T.h.e. Medical Barrie.
[5866070]
Team was preparing to get the patient out of bed using the ceiling lift. The sling had been appropriately positioned under the patient. While the ceiling lift was being lowered into position so that the sling straps could be attached, the lift mechanism literally fell apart - the metal nuts, rings and bolts fell out detaching the lift bar. All components fell down upon the bed striking the patient in the chest. The estimated fall distance was about 18". The cna standing at patient's right side and broke the fall of the components with cna's hands, but that still made impact with the patient's lower chest/upper abdomen (approx 3"-4" above g-tube site). The patient reported they were "fine". Patient's chest and abdomen were examined immediately by the rn. No redness, tenderness, bruising. Chest and abdomen totally mark and injury free. Md examined the patient upon arrival. No injury and no further work-up ordered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043213 |
| MDR Report Key | 4867547 |
| Date Received | 2015-06-18 |
| Date of Report | 2015-06-18 |
| Date of Event | 2015-05-21 |
| Date Added to Maude | 2015-06-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOLLOS |
| Generic Name | TOLLOS |
| Product Code | FNG |
| Date Received | 2015-06-18 |
| Model Number | CIRRUS 600LBS |
| ID Number | CSA NO. 601.1/UL NO 2601-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | T.H.E. MEDICAL BARRIE |
| Manufacturer Address | ONTARIO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-18 |